To evaluate the efficacy and safety of UGN-102 chemoablation for the primary treatment of patients with recurrent low-grade intermediate-risk nonmuscle-invasive bladder cancer.
ENVISION is an ongoing, multinational, single-arm, Phase 3 study in patients with a biopsy-proven recurrence of untreated low-grade intermediate-risk nonmuscle-invasive bladder cancer. Patients received 6 weekly intravesical instillations of UGN-102 (mitomycin; outpatient setting) and were evaluated at 3 months. Patients achieving complete response (CR) (negative cystoscopic examination, cytology, and for-cause biopsy) were surveilled regularly until recurrence, progression, or death. Patients who remain disease-free will be followed up to 5 years, and further results will be reported in the future.
Of 240 patients enrolled, 228 (95%) received all 6 planned doses; 191 (79.6%; 95% CI: 73.9, 84.5) achieved CR at 3 months, with an 82.3% (95% CI: 75.9, 87.1) probability of response 12 months later. Median duration of response was not estimable over a median 13.9-month follow-up period. The most common adverse events (≥5.0% of patients) were dysuria, hematuria, urinary tract infection, pollakiuria, fatigue, and urinary retention; generally mild/moderate and resolved/resolving. Serious adverse events were observed in 29/240 (12.1%), 2 were treatment-related (urinary retention/urethral stenosis), both resolved.
Primary chemoablation with UGN-102 in patients with recurrent low-grade-intermediate-risk-nonmuscle-invasive bladder cancer resulted in a 79.6% CR rate. Patients achieving a CR had an 82.3% likelihood of remaining disease-free 1 year later. The benefit-risk profile was favorable, supporting UGN-102 as a non-surgical alternative for transurethral resection of bladder tumors in this patient population. Limitations of this study included lack of tumor sizing after the diagnostic biopsy.
ClinicalTrials.gov Identifier: NCT05243550.
The Journal of urology. 2024 Oct 24 [Epub ahead of print]
Sandip M Prasad, Dimitar Shishkov, Nikola Vladimirov Mihaylov, Alexandre Khuskivadze, Pencho Genov, Vasyl Terzi, Max Kates, William C Huang, Michael J Louie, Sunil Raju, Brent Burger, Andrew Meads, Mark Schoenberg
Morristown Medical Center/Atlantic Health System and Garden State Urology, Morristown, New Jersey., Department of Urology, University Multiprofile Hospital for Active Treatment, Plovdiv, Bulgaria., Urology Department, LTD Gidmedi, Tbilisi, Georgia., Department of Urology, University Multiprofile Hospital for Active Treatment 'Kanev', Ruse, Bulgaria., Multiprofile Hospital for Active Treatment, Varna, Bulgaria., The Johns Hopkins Medical Institutions, Baltimore, Maryland., NYU Langone Urology Associates, New York, New York., UroGen Pharma, Princeton, New Jersey.